MAUDE Adverse Event Report: AESCULAP AG ACTIV L INF.PLATE S1 SIZE L 5°/SPIKES; IMPLANTS SPINAL MOTION

Model Number	SW996K
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	01/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That an activ l inf.Plate s1 size l 5°/spikes (part # sw996k) was implanted on an unknown date.According to the complainant the patient underwent a revision surgery on (b)(6) 2024.Reportedly the implants were removed due to the patient's complaints of pain.There was no defects found with the implants upon removal.The surgeon felt that the patient's symptoms were psychological in nature as such the complaint was not reported nor was an explant kit requested.The surgeon sent the device to pathology and no growth was found to indicate an infection.The devices are with the hospital and not available for evaluation.The adverse event is filed under aic reference (b)(4).Associated medwatch reports: 2916714-2024-00078 and 2916714-2024-00079.
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for the available lot number; the device was found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: ACTIV L INF.PLATE S1 SIZE L 5°/SPIKES
• Common Device Name: IMPLANTS SPINAL MOTION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 19237142
• Report Number: 2916714-2024-00080
• Device Sequence Number: 20859794
• Product Code: MJO
• UDI-Device Identifier: 04046963143862
• UDI-Public: 4046963143862
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024
• Report Date (Section F): 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/20/2025
• Device Model Number: SW996K
• Device Catalogue Number: SW996K
• Device Lot Number: 52657933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/17/2024
• Device Age: 40 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 09/03/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male
• Date Report Sent to FDA: 05/03/2024